National Plaque Registry and Database (OPeRA)

Semmelweis University

Status: Not yet enrolling

Conditions: Coronary Artery Disease; Atherosclerosis; Cardiovascular Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02578355

The OPeRA study

Details and patient eligibility

About

The ultimate goal of this project is to develop a risk score to identify patients with vulnerable coronary atherosclerotic plaques, who are prone to suffer acute coronary syndrome. Early identification of vulnerable plaques may have an enormous impact on public health through primary and secondary prevention of acute myocardial infarction.

Investigators hypothesize that a risk score that incorporates non-invasive coronary CT imaging (calcium score and/or coronary CTA) in combination with clinical characteristics (classical risk prediction models) will improve the identification of patients who are at highest risk to suffer myocardial infarction or sudden cardiac death.

The overall goal of the OPeRA project is to develop, implement and validate a novel risk assessment tool based on image markers and clinical characteristics to identify patients who are at increased risk to suffer myocardial infarction or sudden cardiac death.

Full description

The primary goals of OPeRA consortium:

To develop a national coronary CTA registry with the collaboration of all major cardiac CT centers of Hungary (Országos Plaque Regiszter és Adatbázis - NatiOnal Plaque Registry and DAtabase, OPeRA).

1. To develop a novel risk assessment tool (OPeRA score) based on image markers and clinical characteristics.
2. To identify and validate novel vulnerable coronary plaque image markers and assess their prognostic value.

Secondary goals:

1. To develop a standardized and structured, national coronary CTA reporting system.
2. To establish a national quality control system that monitors the quantity of iodinated contrast agent and the patients' radiation dose.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Subject providing written informed consent
• Scheduled to undergo a clinically indicated coronary CTA

Exclusion criteria

• Age <18 years
• Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina)
• Recent prior myocardial infarction within 30 days prior to coronary CTA or between coronary CTA and ICA
• Pregnancy or unknown pregnancy status in subject of childbearing potential
• Subject requires an emergent procedure
• Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema
• Inability to comply with study procedures

Trial design

20,000 participants in 1 patient group

Coronary CT Angiography (CCTA)

Description:

Patients included in the OPeRA Registry are those that have previously undergone clinically-indicated CCTA as part of their standard of care.